Sayiner 2001.
| Methods | STUDY DESIGN: parallel LOCATION, NUMBER OF CENTRES: Izmir, Turkey. 1 tertiary centre DURATION OF STUDY: 6 months |
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| Participants | N SCREENED: 198 N RANDOMISED: 36 N COMPLETED: 34 (SCS ≤ 7 n = 17; SCS > 7 n = 17) M = SCS ≤ 7: 16, SCS > 7: 16 F = SCS ≤ 7: 1, SCS > 7: 1 AGE: SCS ≤ 7: 67.4 SCS > 7: 64.1 BASELINE DETAILS: no significant differences between the 2 groups for age, duration of COPD, smoking history, blood eosinophilia, baseline levels of FEV1 Number of exacerbations within 12 months (31 participants): no differences between groups LTOT SCS ≤ 7: 5 (29%); SCS > 7: 2 (12%) Prior medication: ipratropium bromide, long‐acting beta2‐agonists and theophylline INCLUSION CRITERIA: current or ex‐smokers with a smoking history > 20 pack‐years and severe airway obstruction (FEV1 < 35% predicted), who presented with an exacerbation necessitating hospitalisation EXCLUSION CRITERIA: personal or family history of asthma, atopy, allergic disease, presence of eosinophilia, use of systemic steroids within the preceding month, presence of severe hypertension, uncompensated congestive heart failure or uncontrolled (or difficult to control) diabetes mellitus and respiratory failure necessitating mechanical ventilation therapy |
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| Interventions | SCS ≤ 7: methylprednisolone, 0.5 mg/kg IV 6‐hourly for 3 days, followed by normal saline solution as placebo treatment IV twice daily for the following 3 days and once daily for the final 4 days SCS > 7: methylprednisolone, 0.5 mg/kg IV 6‐hourly for the first 3 days, followed by 0.5 mg/kg 12‐hourly for 3 days and 0.5 mg/kg once daily for 4 more days (total 10 days) Co‐interventions: all given high doses of inhaled beta2‐agonists, ipratropium bromide, theophylline (dose determined according to serum level measurements), antibiotics when indicated (presence of increased dyspnoea, sputum volume and sputum purulence) for 10 days, and H2‐receptor antagonists for 10 days, during which they received the study medication TREATMENT PERIOD: 10 days. All participants remained hospitalised for at least 10 days FOLLOW‐UP PERIOD: following 6 months |
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| Outcomes | FEV1and PaO2 levels on day 3 and day 10, absolute group means Arterial blood gas levels day 1, day 3, day 5, day 7 and day 10 (arterial blood gases taken on room air after cessation of supplemental oxygen 30 minutes before, if the participant was on oxygen) Symptom scores (dyspnoea, cough) Recurrence of exacerbation in the following 6 months (collected by review of participants' records) Adverse events. Symptom scores (using 7‐point scale on which higher scores represented better function) |
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| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Randomisation sequence was generated before recruitment of participants. This was done by allocating study participants to odd numbers and the control group to even numbers Randomisation code was broken only after all data were analysed and statistical analysis was performed |
| Allocation concealment (selection bias) | Low risk | Randomisation code was set up and sealed opaque envelopes were prepared before study initiation by one of the study authors (AS), who also prepared the study medications along with the head nurse |
| Blinding (performance bias and detection bias) All outcomes | Low risk | Double‐blind study: participants and data collectors blinded Only the principal investigator (AS) and the head nurse were informed about the randomisation list Participants were blinded to the nature of the IV medications. On inclusion of a participant in the study, the related envelope was opened and the drug package was given to the nurse in charge of treatment Physician/investigator who followed the participant, recorded arterial blood gas results, performed bedside spirometry and assessed symptom scores remained blinded to the study medication |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | 2 withdrawals. 1 from each group, reason given |
| Selective reporting (reporting bias) | Low risk | Days 5 and 7 spirometry and ABG results not included. Reason:A comparison of 3 days vs 10 days of treatment was chosen for the 2 groups because these times were roughly the treatment duration in previous studies showing that steroids were effective. Both regimens were of relatively short duration, and the potential for adverse events was taken into account |